Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 80 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32cm or 40cm image intensifier. GE Healthcare

FDA Recall Z-1485-06 · Posted 2006-09-30

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeJAA
Date Initiated2006-11-01
Date Terminated2008-02-24
Product Quantity83

Reason for Recall

Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv)

Firm Action

Correction to devices is being implemented through GEHC Field Modification Instructions.

Root Cause

Other

Distribution Pattern

within US: CO, IL, LA, MA, MI, NC, PA, SC,TN, VA. OUS to include: Austrailia, Belgium, Burkina Faso, Brazil, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Italy, Republic of Korea, Lebanon, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Taiwan, Republic of China, United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041605PRECISION RXI ANALOG X-RAY SYSTEMGeneral Medical Merate S.P.A · 2004-06-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑